Communication to Improve Shared Decision-Making in ADHD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Communication to Improve Shared Decision-Making in ADHD (NCT02716324), a randomized na study. The primary outcome is Change in Vanderbilt Parent Rating Scales (VPRS).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group study with single masking, completed under the title “Communication to Improve Shared Decision-Making in ADHD.” Its stated purpose was to explore whether an online patient portal plus a Care Manager was more effective than an online portal alone in managing care for children with ADHD. Enrollment was 303. The sponsor was Children’s Hospital of Philadelphia. The recorded phase is NA.

Both arms used the ADHD Portal. In the comparator arm, the portal served as an electronic communication tool among clinicians, teachers, and parents. In the other arm, those participants also interacted with a Care Manager, and external mental health providers could interact with the CM as well. The CM had access to information in the portal. The registry description says the CM met with participants to discuss the child’s care and communicated the parent’s goals and preferences to the doctor and teacher.

The primary outcome was parent-rated ADHD symptoms on the VPRS. Measurements were scheduled at Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The registry describes the Visit 4 time range as one value. Secondary outcomes included goal attainment, treatment initiation and use of services, treatment adherence and use of services, school performance, student engagement, teacher connectedness, peer relationships, and family relationships.

The trial is recorded as completed. The registry record gives the start date as 2016-03-10 and primary completion date as 2018-05-09. It does not report the planned analysis model, the masking procedure in operational detail, or a sample-size justification.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Eligible participants were excluded prior to enrollment if they had history of suicide, bipolar disorder, schizophrenia, autism, or conduct disorder.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Row differs from the overall number due to missing data.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Vanderbilt Parent Rating Scales (VPRS), measured over Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4).

The primary endpoint was change in Vanderbilt Parent Rating Scales (VPRS) scores. The VPRS is a public domain measure completed by a child’s parent. Although the instrument includes ADHD symptom, performance, and side-effect items, the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD symptoms.

Each symptom item uses a 4-point Likert rating from “never” to “very often.” The total score ranges from 0-54, with higher scores indicating worse outcome. The registry identifies the outcome as a mean score with standard deviation as the dispersion measure. Assessments were scheduled at baseline and at 3 months, 6 months, and 9-12 months. Visit 4 represents a time range counted as a single value.

Repeated parent ratings can describe symptom levels at more than one stage of follow-up, while change focuses on how scores vary from baseline. This can be useful for comparing the pattern of reported symptoms over time between randomized arms. A mean describes the group’s average score, while a standard deviation describes the spread of scores among participants. Neither alone describes the uncertainty in an estimated difference between arms. Numerical means, changes, arm contrasts, and confidence intervals are not reported in the registry record, so the size and precision of any observed difference cannot be assessed from the available outcome information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods turn observed measurements into estimates that address a study question. For a randomized comparison, the key result is often an estimated difference between arms, accompanied by an indication of its uncertainty. The registry record identifies a mean continuous outcome and a standard deviation, but does not report a primary-outcome estimate, confidence interval, test statistic, or model. The particular inferential method used for the VPRS comparison is not reported in the registry record.

What does a mean describe?

A mean is the arithmetic average of measured scores in a group. For this study, the score is the total from the 18 ADHD symptom items, with higher scores indicating worse outcome. A mean can summarize a group at a visit, but it does not show how much individual participants vary. The standard deviation describes that spread. It is not the same as the standard error, which concerns uncertainty in an estimated mean, nor is either quantity by itself an estimate of the difference between randomized arms.

Why does change over time require a clear contrast?

The endpoint was measured repeatedly: at baseline, 3 months, 6 months, and 9-12 months. A comparison could address scores at one follow-up, changes relative to baseline, or the overall trajectory across visits. These are different statistical questions and need not produce identical estimates. A model for repeated measurements can account for the fact that observations from the same participant are related. The registry record does not identify a repeated-measures model, a selected visit contrast, or the way within-participant correlation was handled.

Change scores compare a follow-up measurement with baseline for the same participant. Comparing change between randomized arms can help focus on whether the groups changed differently, but the interpretation depends on how the change is defined and analyzed. The endpoint title says “Change in Vanderbilt Parent Rating Scales (VPRS),” yet numerical changes and the corresponding between-arm estimate are not reported in the registry record. It is therefore not possible to reconstruct or interpret that contrast.

What does a confidence interval add?

A confidence interval expresses the uncertainty around an estimated effect under the assumptions of the analysis. Its location indicates which effect values are compatible with the data and method, while its width indicates precision. A narrow interval is more precise than a wide interval, but precision alone does not establish clinical importance. The registry record does not report a confidence interval for the primary outcome. General statistical interpretation of such an interval cannot replace the missing trial estimate.

What can a significance test tell a reader?

A significance test evaluates compatibility between observed data and a specified null hypothesis under an analysis model. A p-value is not the probability that the null hypothesis is true, nor does it describe the size of an effect. A p-value also cannot communicate precision or practical importance on its own. No primary-outcome p-value or test is reported in the registry record, and the statistical plan that would identify the test is not reported there.

The record includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as stated fractions of the observed effect. Those are described as planning illustrations based on the observed effect, not as the trial’s own design. Such illustrations are not observed power and do not replace a confidence interval or outcome analysis. The registry record does not report the trial’s sample-size justification.

Why does variability matter?

Variability describes how dispersed measurements are. If scores differ substantially among participants, a group mean alone can hide that spread. In general, greater variability can make a group comparison less precise for a given amount of information. The VPRS outcome lists standard deviation as its dispersion measure, but the arm-specific standard deviations are not reported in the registry record. Over-dispersion is a general concern when data vary more than a model assumes; no finding of over-dispersion or method for addressing it is reported for this outcome.

Interpretation also depends on missing observations, the analysis population, and the prespecified approach to multiple outcomes or time points. Those features influence which data contribute to an estimate and how uncertainty is quantified. The registry record notes missing data in the primary-outcome row but does not describe a missing-data method or multiplicity plan. Consequently, a complete account of the primary analysis cannot be recovered from the registry information.

10. Multiplicity, Missing Data and Analysis Populations

The study lists a primary outcome measured at multiple visits and several secondary outcomes. Multiple outcomes or time-point comparisons can create multiplicity: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Statistical plans may address this by identifying a primary contrast in advance, adjusting tests, or treating some analyses as exploratory. Which approach was used for this trial is not reported in the registry record. The record says the primary outcome has several categories or time points and was not reduced to one comparison, so no single primary contrast can be identified from the posted information.

The record lists 10 outcome measures and 20 analyses. These counts do not reveal which analyses were confirmatory, how outcomes were grouped, whether any multiplicity adjustment was made, or how analyses were prioritized. A count alone should not be treated as evidence that results were or were not adjusted. The statistical plan and any multiplicity procedure are not reported in the registry record.

For the VPRS, the record explicitly notes that the outcome row differs from the overall number because of missing data. It does not report the number of participants with measurements at each visit, the pattern or reasons for missingness, or the analysis population used for the primary result. It also does not describe whether missing values were handled through a model, imputation, complete-case analysis, or another method. These choices can affect both the estimate and its uncertainty, so the missing-data approach cannot be evaluated from the registry information.

The registry record does not describe an intention-to-treat analysis population, a per-protocol population, exclusions after randomization, or the handling of participants with incomplete follow-up. Those details should not be inferred from the randomized design or enrollment count. Without the analysis population and prespecified analysis strategy, readers cannot determine whether the posted outcome information represents all randomized participants or a subset.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists serious adverse events separately for the ADHD Portal arm and the ADHD Portal Plus Care Manager arm. For each arm, the number at risk for serious adverse events is reported alongside the number affected. The portal arm lists 149 at risk and 0 affected; the portal-plus-Care-Manager arm lists 154 at risk and 0 affected. Deaths are reported as 0 in each arm. The record also reports 149 and 154 at risk for other adverse events, with 0 affected in each arm.

These are descriptive counts in the registry record. They indicate that no serious adverse events or deaths are listed as observed among the participants counted at risk in either arm. They do not establish that no adverse events occurred outside the categories or reporting period represented by these fields. The registry information does not give event-level descriptions, exposure time, ascertainment procedures, or a detailed safety-analysis plan. It also does not provide a statistical comparison of safety between arms.

Zero reported events should not be read as proof that the underlying risk is zero. The counts describe what was recorded for this trial, and their interpretation depends on how events were collected and reported. Those procedures are not described in the registry record. The serious-event figures therefore support a narrow descriptive statement about the posted counts, not a broader conclusion about safety.

12. What the Result Does, and Does Not, Mean

This trial addresses a specific care-delivery question: whether adding a Care Manager to an ADHD Portal was associated with a different pattern of parent-rated ADHD symptom scores than using the portal alone. Both arms used the portal, so the comparison is about the additional CM component rather than portal access versus no portal. The study’s described communication pathway involved parents, clinicians, teachers, and, in the intervention arm, potentially external mental health providers.

The registry record identifies a randomized, parallel-group design, enrollment of 303, a continuous primary measure, and assessments from baseline through 9-12 months. Those details explain the structure of the comparison, but they are not outcome evidence. The numerical primary results, between-arm estimates, confidence intervals, and statistical tests are not reported in the registry record. The direction, size, and precision of any difference therefore cannot be stated from this information.

The VPRS measures parent-reported ADHD symptoms using 18 symptom items. It is one dimension of the care question, not a complete account of every outcome that might matter to children and families. The registry also lists goal attainment, treatment and service use, school performance, engagement, connectedness, and relationship outcomes. The posted description does not establish how any of these secondary outcomes changed or how they relate to the primary measure.

Even if numerical outcome estimates were available, statistical evidence would need to be interpreted with attention to uncertainty, missing data, multiple outcomes, and the analysis plan. Those details are not reported for the primary analysis in the registry record. The record’s missing-data note further cautions against treating overall enrollment as the number contributing to every endpoint assessment.

Accordingly, the information supports describing the intended comparison and the measurement approach, but not claiming that one approach improved symptoms or that the approaches were equivalent. Absence of numerical results in this registry record is not itself evidence of no effect. Nor does a design description establish the generalizability of findings beyond the study’s care context.

13. Why This Trial Matters Statistically

The trial is statistically interesting because it compares an added communication and care-coordination component against a portal already described as standard of care at the institution. That structure focuses the question on the incremental contribution of the Care Manager within an existing electronic communication approach. The randomized, parallel-group design provides a basis for a comparative evaluation, while the outcome schedule makes change over time central to interpretation.

The VPRS is a continuous symptom score measured repeatedly, rather than a single event outcome. This means interpretation would ideally distinguish group averages at visits from the difference in change between arms and from the overall pattern across visits. The registry record names the measure and timepoints but does not identify a primary contrast or a model for the repeated observations. That missing detail is statistically important because it determines precisely what the analysis estimates.

The record also illustrates why enrollment is not necessarily the same as the analyzed population for every endpoint. It explicitly notes that the primary-outcome row differs from the overall number because of missing data. Without the numbers available at each visit or the missing-data method, the impact of incomplete measurement cannot be assessed.

Finally, the trial has multiple listed outcomes and analyses, while the registry information does not state a multiplicity strategy or identify which comparisons were prespecified. This affects how isolated findings should be interpreted if results are reported elsewhere. The record therefore offers a useful design and measurement description, but a statistically complete interpretation requires outcome estimates, uncertainty measures, and analysis details that are not reported in the registry record.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

A central limitation of the registry information is the absence of numerical primary-outcome results. There are no arm means, changes, between-arm estimates, confidence intervals, or p-values for the VPRS. The primary outcome spans several visits, and the record says it was not reduced to one comparison. Thus, neither the primary contrast nor the result’s direction and precision can be evaluated from the posted information.

The outcome population differs from overall enrollment because of missing data, but the record does not specify the number of available observations at each visit, reasons for missingness, or the method used to handle incomplete records. It does not identify the analysis population or describe exclusions after randomization. These omissions prevent assessment of whether missingness could affect the comparison.

The registry lists multiple secondary outcomes and analyses but does not describe a statistical analysis plan, multiplicity control, or hierarchy of outcomes. It also does not report a sample-size justification. Planning illustrations based on observed effects are described separately from the trial’s own design, but they do not supply evidence about the primary outcome or its precision.

Additional operational detail is limited. Although masking is recorded as single, the identity of the masked parties and implementation are not reported in the registry record. The record describes the intervention components but does not give enough information to evaluate variation in how the CM interactions were delivered. No assumptions about adherence, protocol deviations, or analysis methods should be inferred from the descriptions alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Communication to Improve Shared Decision-Making in ADHD — NCT02716324.
• Registry record last updated 2019-11-25; status last verified 2019-11.
• Results first posted 2019-09-27.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT02716324, “Communication to Improve Shared Decision-Making in ADHD,” is recorded as a completed randomized, single-masked, parallel-group study sponsored by Children’s Hospital of Philadelphia. Enrollment was 303. The study compared the ADHD Portal alone with the portal plus a Care Manager for children with ADHD.

The primary outcome was change in parent-completed VPRS symptom scores, assessed at baseline, 3 months, 6 months, and 9-12 months. Higher scores indicated worse outcome. The registry record notes missing data in the primary-outcome population and does not report numerical primary results or a single comparison across the visits. It also does not report the primary analysis method, missing-data approach, or multiplicity plan.